(21 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of examination gloves, with no mention of AI or ML.
No
The device, examination gloves, is intended to prevent contamination between patient and examiner, not to treat or cure a disease or condition.
No
Explanation: The "Intended Use / Indications for Use" section states the device is "a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device, not a diagnostic one. There is no mention of the device being used to identify, detect, or monitor a medical condition.
No
The device is a physical product (gloves) and the summary describes physical properties and performance tests, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Intended Use: The intended use of these gloves is to be worn on the examiner's hand or finger to prevent contamination between the patient and examiner. This is a physical barrier function, not a diagnostic test performed on a specimen.
- Lack of Diagnostic Information: The device description and performance studies focus on the physical properties and safety of the gloves (dimensions, strength, freedom from pinholes, biocompatibility). There is no mention of analyzing biological samples or providing diagnostic information about a patient's health.
Therefore, based on the provided information, these gloves are a medical device used for barrier protection, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Powdered Free Vinyl Patient Examination Gloves, Light Yellow Color is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LYZ
Device Description
Powdered Free Vinyl Patient Examination Gloves, Light Yellow Color that meets all of the requirements of ASTM standard D 5250-06e1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical tests were conducted. The device meets requirements per ASTM D5250-06 el, per ASTM D6124-06, per 21 CFR 800.20 and FDA recognition number 2-152; AAMI / ANSI / ISO 10993-10:2002/Amd. 1:2006. Clinical data was not needed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
| Characteristics | Standard | Device performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 e1. | Meets |
| Physical Properties | ASTM standard D 5250-06 e1. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 e1 and D6124-06 |
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Section C 510(k) Summary (21 CFR 807.92)
JUN 1 6 2011
510(K) Summary
"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."
11450 " (applicant leave blank) "The assigned 510(k) number is:
Premarket Notification [510(k)] Summary
[(a)(1)]. The summary contains on the first page, preferably on your letterhead paper, the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared :
Submitter's name : JIANGSU ALFA GLOVE CO., LTD 10 District A, Standard Factory, The Economic Submitter's address : Development Zone, Suqian, Jiangsu, 223800, China 86-527-88286055 Phone number : 86-527-88286000 Fax number : Name of contact person: Mr.ChenFeng Zhang May 10, 2011 Date the summary was prepared:
[(a)(2)]. The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known_
Device Name:
Powdered Free Vinyl Patient Examination Gloves, Light Yellow Color
Proprietary/Trade name:
Powdered Free Vinyl Patient Examination Gloves, Light Yellow Color Other clients private labeling
Common Name: Classification Name: Device Classification: Regulation Number: Panel: Product Code:
Exam gloves Patient examination glove 1 21 CFR 880.6250 General Hospital (80) LYZ
[(a)(3)]. An identification of the legally marketed device to which your firm is claiming substantial equivalence .
Class 1* Powdered Free Vinyl Patient Examination Gloves, Light Yellow Color that meets all of the requirements of ASTM standard D 5250-06e1.
Section C
1411
1
[(a)(4)] A description of the device
Device Description: Powdered Free Vinyl Patient Examination Gloves, Light Yellow Color that meets all of the requirements of ASTM standard D 5250-06e1.
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: Powdered Free Vinyl Patient Examination Gloves, Light Yellow Color is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
[(a)(6)] A summary of the technological characteristics of new device compared to the predicate device.
The Powdered Free Vinyl Patient Examination Gloves, Light Yellow Color, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard | Device performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 e1. | Meets |
| Physical Properties | ASTM standard D 5250-06 e1. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 e1 | |
| and D6124-06 |